FDA: Check in With Us Early When Submitting NDAs for Hormones

Drugmakers producing hormones should consult with the FDA before seeking to opt out of an environmental assessment because of the impact of those drugs on the water supply.

Failure to consult the agency could result in substantial delays on NDAs for therapies that affect testosterone and estrogen levels or the thyroid, the FDA says in final guidance released last week.

Under the National Environmental Policy Act, federal agencies are required to weigh the environmental impact of their decisions, and the FDA makes that determination by ordering companies to conduct an assessment of a drug’s environmental impact.